Passive Double Drive Member Activated Safety Blood Collection Device

ABSTRACT

A shieldable needle device including a drive member is disclosed. The drive member is extendable between a biased position and an extended position for moving a tip guard from an first position to a second position in which the tip guard shields a distal end of the needle cannula. The shieldable needle device includes a pair of wings extending laterally from opposing sides of the hub that are movable between a laterally extending position and a dorsal position. With the wings in the dorsal position, the wings retain the drive member in the biased position thereby maintaining the tip guard in the first position. Movement of the wings from the dorsal position to the laterally extending position releases retainment of the drive member. A second drive member may be included.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to a blood collection devicefor safe and convenient handling of needles. More particularly, thepresent disclosure relates to an inexpensive disposable blood collectiondevice including a passively activated safety shield device forprotectively shielding a pointed end of a needle assembly.

2. Description of the Related Art

Disposable medical devices that have piercing elements are typicallyused for administering a medication or withdrawing a fluid, such asblood collecting needles or fluid handling needles. Current medicalpractice requires that the fluid containers and needle assemblies usedin such systems be inexpensive and readily disposable. Consequently,existing blood collection systems, for example, typically employ someform of a durable, reusable holder on which detachable and disposableneedles and fluid collection tubes may be mounted. A blood collectionsystem of this nature can be assembled prior to use and thendisassembled after usage. Accordingly, these blood collection systemsallow repeated use of the relatively expensive holder upon replacementof the relatively inexpensive needle and/or fluid collection tube. Inaddition to reducing the cost of collecting blood specimens, these bloodcollection systems also help minimize the production of hazardousmedical waste.

A blood collection set or intravenous (IV) infusion set typicallyincludes a needle cannula having a proximal end, a pointed distal end,and a lumen extending therebetween. The proximal end of the needlecannula is securely mounted in a plastic hub with a central passage thatcommunicates with the lumen through the needle cannula. A thin flexiblethermoplastic tube is connected to the hub and communicates with thelumen of the needle cannula. The end of the plastic tube, remote fromthe needle cannula, may include a fixture for connecting the needlecannula to a blood collection tube or some other receptacle. Thespecific construction of the fixture will depend upon thecharacteristics of the receptacle to which the fixture will beconnected.

In order to reduce the risk of incurring an accidental needle-stickwound, protection of used needle tips becomes important. With concernabout infection and transmission of diseases, methods and devices toenclose the used disposable needle have become very important and ingreat demand. For example, needle assemblies commonly employ a safetyshield that can be moved into shielding engagement with a used needlecannula without risking an accidental needle stick.

SUMMARY OF THE INVENTION

The present disclosure provides a shieldable needle device including inone embodiment, a first drive member and a second drive member. Thefirst drive member and the second drive member are each extendablebetween a folded biased position and an extended position for moving atip guard from a proximal position adjacent a hub supporting theproximal end of a needle cannula to a distal position in which the tipguard protectively surrounds the distal end of the needle cannula. Theshieldable needle device includes a wing assembly having a pair of wingsextending laterally from opposing sides of the hub and that are movablebetween a laterally extending position and a dorsal position. With thepair of wings in the dorsal position, the wings retain the first drivemember and the second drive member in the folded biased position therebymaintaining the tip guard in the proximal position. Movement of thewings from the dorsal position to the laterally extending positionreleases retainment of the first drive member and the second drivemember thereby allowing the first drive member and the second drivemember to unfold to the extended position and move the tip guard fromthe proximal position to the distal position.

In certain embodiments of the shieldable needle device of the presentdisclosure, the first drive member is separate and distinct from thesecond drive member. Advantageously, by having two separate drivemembers, the shieldable needle device of the present disclosure providesfor better and more consistent locking out of the tip guard to thedistal position in which the tip guard protectively surrounds andshields the distal end of the needle cannula. This is achieved becauseby having two separate drive members, a greater force that the two drivemembers extend from the folded biased position to the extended positioncan be achieved. In this manner, the shieldable needle device of thepresent disclosure provides more consistent locking out of the tip guardto the distal position in which the tip guard protectively surrounds andshields the distal end of the needle cannula. Furthermore, by having twoseparate drive members, more control can be exerted over the abovedescribed extension force of the two drive members to the extendedposition.

Another advantage of the two drive members of the shieldable needledevice of the present disclosure is that the two drive members provide agreater shielding of the needle cannula. For example, referring to FIGS.6 and 7, by having two separate drive members, a greater area of theneedle cannula is protectively surrounded and safely shielded. As shownin FIGS. 6 and 7, the two drive members, together with the tip guardassembly, substantially completely surround and shield the needlecannula. Furthermore, the two separate drive members provide additionalside shielding guards for the needle cannula. In this manner, no portionof the needle cannula is exposed thereby significantly reducing the riskof accidental needle stick injuries.

In accordance with an embodiment of the present invention, a shieldableneedle device includes a needle cannula having a proximal end and adistal end, and a hub supporting at least a portion of the needlecannula. The device further includes a wing assembly having at least apair of wings extending from opposing sides of the hub, the pair ofwings movable between a laterally extending position and a dorsalposition. The device also includes a tip guard axially movable withrespect to the needle cannula from a first position adjacent the hub toa second position in which the tip guard shields the distal end of theneedle cannula. A drive member is also provided which is extendablebetween a biased position and an extended position for moving the tipguard from the first position to the second position, the drive memberhaving a proximal end engaged with the hub and a distal end engaged withthe tip guard. With the pair of wings in the dorsal position, the pairof wings retain the drive member in the biased position therebymaintaining the tip guard in the proximal position, and movement of thepair of wings from the dorsal position to the laterally extendingposition releases the drive member thereby allowing the drive member totransition to the extended position and advance the tip guard from theproximal position to the distal position.

In certain configurations, the device includes a second drive memberextendable between a biased position and an extended position for movingthe tip guard from the first position to the second position, the seconddrive member having a proximal end engaged with the hub and a distal endengaged with the tip guard. In certain configurations, with the pair ofwings in the dorsal position, the pair of wings retain the drive memberand the second drive member in the biased position thereby maintainingthe tip guard in the proximal position. Movement of the pair of wingsfrom the dorsal position to the laterally extending position releasesthe drive member and the second drive member, thereby allowing the drivemember and the second drive member to transition to the extendedposition and advance the tip guard from the proximal position to thedistal position. The proximal end of the drive member may be connectedto an opposite side of the hub from the proximal end of the second drivemember. The distal end of the drive member may be connected to anopposite side of the tip guard from the distal end of the second drivemember.

In other configurations, the device may further include a coverprotectively surrounding the needle cannula and maintaining the pair ofwings in the dorsal position. The cover may define a slot area forreceiving and maintaining the pair of wings in the dorsal position. Incertain configurations, the pair of wings are formed with the hub. Thepair of wings may be formed of a resilient flexible material.Optionally, the drive member is formed of a resilient flexible material.

The tip guard may include a tip guard housing formed from a plasticmaterial and a metallic spring clip mounted to the tip guard housing.The spring clip may be biased against the needle cannula with the tipguard in the proximal position and the spring clip may be disposed overthe distal end of the needle cannula with the tip guard in the distalposition. The drive member may be at least partially folded in thebiased position. In certain situations, both the drive member and thesecond drive member are at least partially folded in the biasedposition.

In accordance with another embodiment of the present invention, ashieldable needle device includes a needle cannula having a proximal endand a distal end, and a hub supporting at least a portion of the needlecannula. The device includes a wing assembly having at least a pair ofwings extending from opposing sides of the hub, the pair of wingsmovable between a laterally extending position and a dorsal position,with the pair of wings in the dorsal position a gap is formed betweenthe hub and the pair of wings. The device also includes a tip guardaxially movable with respect to the needle cannula from a first positionadjacent the hub to a second position in which the tip guard shields thedistal end of the needle cannula. The device further includes a drivemember extendable between a biased position and an extended position formoving the tip guard from the first position to the second position, thedrive member having a proximal end engaged with the hub and a distal endengaged with the tip guard. With the pair of wings in the dorsalposition and the drive member in the biased position, a portion of thedrive member is retained within the gap between the hub and the pair ofwings.

In certain configurations, the device further includes a second drivemember extendable between a biased position and an extended position formoving the tip guard from the first position to the second position, thesecond drive member having a proximal end engaged with the hub and adistal end engaged with the tip guard. With the pair of wings in thedorsal position and the drive member and the second drive member in thebiased position, a portion of at least one of the drive member and thesecond drive member may be retained within the gap between the hub andthe pair of wings. With the pair of wings in the dorsal position and thedrive member and the second drive member in the biased position, aportion of both the drive member and the second drive member may beretained within the gap between the hub and the pair of wings. The pairof wings may retain the drive member and the second drive member in afolded position thereby maintaining the tip guard in the proximalposition, and movement of the pair of wings from the dorsal position tothe laterally extending position may release retainment of the drivemember and the second drive member thereby allowing the drive member andthe second drive member to unfold to the extended position and move thetip guard from the proximal position to the distal position.

In certain configurations, the drive member is separate from the seconddrive member. The proximal end of the drive member may be connected toan opposite side of the hub from the proximal end of the second drivemember. The distal end of the drive member may be connected to anopposite side of the tip guard from the distal end of the second drivemember. The drive member may be formed of a resilient flexible material.

Optionally, the tip guard includes a tip guard housing formed from aplastic material and a metallic spring clip mounted to the tip guardhousing. The spring clip may be biased against the needle cannula withthe tip guard in the proximal position and the spring clip may bedisposed over the distal end of the needle cannula with the tip guard inthe distal position.

In accordance with another embodiment of the present invention, ashieldable needle device includes a needle cannula having a proximal endand a distal end, and a retainer member supporting the proximal end ofthe needle cannula, the retainer member movable between an open positionand a retaining position. The device also includes a tip guard axiallymovable with respect to the needle cannula from a first positionadjacent the retainer member to a second position in which the tip guardshields the distal end of the needle cannula. The device includes afirst drive member extendable between a biased position and an extendedposition for moving the tip guard from the first position to the secondposition, the first drive member having a proximal end connected to theretainer member and a distal end connected to the tip guard. The devicealso includes a second drive member extendable between a biased positionand an extended position for moving the tip guard from the firstposition to the second position, the second drive member having aproximal end connected to the retainer member and a distal end connectedto the tip guard. With the retainer member in the retaining position,the retainer member retains the first drive member and the second drivemember in the biased position thereby maintaining the tip guard in thefirst position. Movement of the retainer member from the retainingposition to the open position releases retainment of the first drivemember and the second drive member thereby allowing the first drivemember and the second drive member to transition to the extendedposition and move the tip guard from the first position to the secondposition.

In certain configurations, the first drive member and the second drivemember are at least partially folded in the biased position. Optionally,movement of the retainer member from the retaining position to the openposition releases retainment of the first drive member and the seconddrive member thereby allowing the first drive member and the seconddrive member to unfold to the extended position and move the tip guardfrom the first position to the second position.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings.

FIG. 1 is an exploded, perspective view of a shieldable needle device inaccordance with an embodiment of the present invention.

FIG. 2 is an assembled, perspective view of the shieldable needle deviceof FIG. 1 in accordance with an embodiment of the present invention.

FIG. 3 is a perspective view of the shieldable needle device of FIG. 2with a packaging cover being removed in accordance with an embodiment ofthe present invention.

FIG. 4 is a perspective view of the shieldable needle device of FIG. 2with the packaging cover removed, with a wing assembly in a dorsalposition, and first and second drive members in a folded biased positionin accordance with an embodiment of the present invention.

FIG. 5 is a cross-sectional view taken along line 5-5 of the shieldableneedle device of FIG. 4 in accordance with an embodiment of the presentinvention.

FIG. 6 is a perspective view of the shieldable needle device of FIG. 2with the packaging cover removed, with the wing assembly in a laterallyextending position, and the first and second drive members in anextended position in accordance with an embodiment of the presentinvention.

FIG. 7 is a plan view of the shieldable needle device of FIG. 6 inaccordance with an embodiment of the present invention.

FIG. 8 is a cross-sectional view taken along line 8-8 of the shieldableneedle device of FIG. 6 in accordance with an embodiment of the presentinvention.

FIG. 9A is a perspective view of an exemplary connection means, in anopen position, between a first drive member or a second drive member anda hub or a tip guard assembly of the shieldable needle device of FIG. 1in accordance with an embodiment of the present invention.

FIG. 9B is a side elevation on cross-sectional view of the exemplaryconnection on means of FIG. 9A, in a locked position, between a firstdrive member or a second drive member and a hub or a tip guard assemblyof the shieldable needle device of FIG. 1 in accordance with anembodiment of the present invention.

FIG. 10 is a perspective view of another exemplary connection means, ina locked position, between a first drive member or a second drive memberand a hub or a tip guard assembly of the shieldable needle device ofFIG. 1 in accordance with an embodiment of the present invention.

FIG. 11 is a perspective view of yet another exemplary connection means,in an open position, between a first drive member or a second drivemember and a hub or a tip guard assembly of the shieldable needle deviceof FIG. 1 in accordance with an embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

In the following discussion, “distal” refers to a direction generallytoward an end of a needle assembly adapted for contact with a patient,and “proximal” refers to the opposite direction of distal, i.e., awayfrom the end of a needle assembly adapted for contact with a patient.For purposes of this disclosure, the above-mentioned references are usedin the description of the components of a shieldable needle device inaccordance with the present disclosure.

Referring to FIGS. 1 and 2, a blood collection assembly 10 includes ashieldable needle device 12, a flexible tube 14 extending fromshieldable needle device 12, a fixture 16 mounted to tube 14, and apackaging cover 18 removably mounted to portions of shieldable needledevice 12 opposite tube 14. In one embodiment, cover 18 may be removablymounted to shieldable needle device 12 through a frictional engagement,interference fit, or similar securement method. Blood collectionassembly 10 includes a needle cannula 20 having a proximal end 32, anopposing distal end 34, and a lumen 36 extending between the ends.Proximal end 32 of needle cannula 20 is securely mounted with a hub 22so that a central passage 44 of hub 22 is in fluid communication withlumen 36 of needle cannula 20.

Thin flexible thermoplastic tubing 14 may be connected to hub 22 so thattubing 14 is in fluid communication with lumen 36 of needle cannula 20.For example, flexible tubing 14 can be mounted to a proximal end 40 ofhub 22 such that the passage through tubing 14 communicates with lumen36 of needle cannula 20. The end of tubing 14 remote from needle cannula20 may include fixture 16 mounted thereon for connecting needle cannula20 to a blood collection tube or some other receptacle. For example,fixture 16 enables needle cannula 20 and tubing 14 to be placed incommunication with an appropriate receptacle, such as a blood collectiontube. The specific construction of fixture 16 will depend upon thecharacteristics of the receptacle to which fixture 16 will be connected.

Blood collection assembly 10 can be packaged substantially in thecondition shown in FIG. 2 in protective packaging, such as in a blisterpackage. Prior to use, blood collection assembly 10 is removed from anyprotective package, and fixture 16 may be connected to an appropriatereceptacle for providing fluid communication with lumen 36 extendingthrough needle cannula 20 as will described in more detail below.

Referring to FIGS. 1 and 4-8, shieldable needle device 12 includespackaging cover 18, needle cannula 20, hub 22, a tip guard assembly 24,a wing assembly 26, a first drive member 28, and a second drive member30. First drive member 28 and second drive member 30 are configured formoving tip guard assembly 24 as will be described in more detail below.

Referring to FIG. 1, first drive member 28 is separate and distinct fromsecond drive member 30. By having two separate drive members 28 and 30,shieldable needle device 12 provides for better and more consistentlocking out of tip guard assembly 24 to the distal position (FIGS. 6-8)in which tip guard assembly 24 protectively surrounds and shields distalend 34 of needle cannula 20. This is achieved because by having twoseparate drive members 28 and 30, a greater force that drive members 28and 30 extend from the folded biased position (FIGS. 2-5) to theextended position (FIGS. 6-8) can be achieved. In this manner,shieldable needle device 12 provides more consistent locking out of tipguard assembly 24 to the distal position in which the tip guard assembly24 protectively surrounds and shields distal end 34 of needle cannula20. The two drive members 28 and 30 also provide a greater shielding ofneedle cannula 20. Referring to FIGS. 6 and 7, by having two separatedrive members 28 and 30, a greater area of needle cannula 20 isprotectively surrounded and safely shielded. As shown in FIGS. 6 and 7,the two drive members 28 and 30, together with tip guard assembly 24,substantially completely surround and shield needle cannula 20.Furthermore, the two separate drive members 28 and 30 provide additionalside shielding guards for needle cannula 20. In this manner, no portionof needle cannula 20 is exposed thereby significantly reducing the riskof accidental needle stick injuries.

Referring to FIG. 1, needle cannula 20 includes a proximal end 32 and anopposing distal end 34, with lumen 36 extending through needle cannula20 from proximal end 32 to distal end 34. Distal end 34 of needlecannula 20 is beveled to define a sharp puncture tip 38, such as anintravenous puncture tip. Puncture tip 38 is provided for insertion intoa patient's blood vessel, such as a vein, and is therefore designed toprovide ease of insertion and minimal discomfort during venipuncture.

Referring to FIG. 1, shieldable needle device 12 includes hub 22. In oneembodiment, hub 22 is a unitary structure, desirably molded from athermoplastic material. In another embodiment, hub 22 may be integrallyformed with wing assembly 26 as discussed below. In such an embodiment,the integral component of hub 22 and wing assembly 26 forms a retainermember that supports proximal end 32 of needle cannula 20 and that ismovable between an open position (FIGS. 6-8) and a retaining position(FIGS. 2-5).

Hub 22 includes a proximal end 40, an opposing distal end 42, and isdefined by a rigid structure or hub structure 46 extending between theends. Hub 22 also includes hub connecting tube 52 disposed within acentral cavity portion of hub structure 46 and defining a distal opening54 for receiving proximal end 32 of needle cannula 20. In this manner,hub 22 is configured to support proximal end 32 of needle cannula 20.Needle cannula 20 can be positioned within distal opening 54 of hub 22so that a portion of needle cannula 20 extends from distal end 42 of hub22. In one embodiment, needle cannula 20 and hub 22 may be separateparts which are fixedly attached and secured through an appropriatemedical grade adhesive, for example, epoxy or similar adhesive material.In another embodiment, needle cannula 20 and hub 22 may form an integralcomponent. For example, needle cannula 20 and hub 22 may be integrallymolded in a two-step molding process. Hub connecting tube 52 alsodefines a proximal opening 56 which is adapted to receive flexible tube14 as shown in FIG. 2, or other medical device, such as a tube holder orsimilar component. Hub connecting tube 52 also defines a central passage44 extending through hub connecting tube 52 from proximal end 40 todistal end 42.

Hub 22 includes structure for mating with first drive member 28 andsecond drive member 30. For example, a first side surface 58 of distalend 42 of hub 22 may include a first connection element 48 and a secondconnection element 50 for connection with first drive member 28. Anopposing second side surface 60 of distal end 42 of hub 22 may alsoinclude a first connection element 48 and a second connection element 50for connection with second drive member 30. In one embodiment, firstconnection element 48 and second connection element 50 may include twobutton elements 62 for connection with first drive member 28 and seconddrive member 30, respectively, as will be discussed in more detailbelow. In other embodiments, hub 22 may include different types ofstructures for mating with first drive member 28 and second drive member30 as will be described in more detail below and with reference to FIGS.9A-11.

Referring to FIG. 1, shieldable needle device 12 includes wing assembly26. In one embodiment, wing assembly 26 may be a unitary structure,desirably formed of a flexible material. As discussed above, in anotherembodiment, hub 22 and wing assembly 26 may be integrally molded in atwo-step molding process. In one embodiment, hub 22 may be formed from athermoplastic material and wing assembly 26 may be formed of a flexiblematerial.

In some embodiments, hub 22 and wing assembly 26 are separate piecesrather than being integrally molded. In one such embodiment, hub 22 andwing assembly 26 may be separate parts which are fixedly attached andsecured through an appropriate medical grade adhesive, for example,epoxy or similar adhesive material. In other embodiments, hub 22 may besecured to wing assembly 26 by a snap fit mechanism, a locking tabmechanism, a spring loaded locking mechanism, a latch, or other similarmechanism.

Wing assembly 26 includes a body portion 64 extending between a pair ofwings 66 and 68, i.e., a first wing 66 and a second wing 68. In anembodiment in which hub 22 and wing assembly 26 are separate parts, bodyportion 64 of wing assembly 26 may be fixedly attached to the underside63 of hub 22, thereby allowing wings 66 and 68 to extend laterally fromhub structure 46 at opposing sides thereof. Wing assembly 26 provides acomponent for assisting in positioning, stabilizing, and placement ofshieldable needle device 12 and blood collection assembly 10 during ablood collection procedure. Wings 66 and 68 are preferably formed of aflexible material, and are movable between a relaxed, laterallyextending position (FIGS. 6-8) in which they are substantially planar,to a bent dorsal position (FIGS. 2-5). In one embodiment, wings 66 and68 may be a preformed bent structure. In other embodiments, wings 66 and68 may also be a planar structure, for example, body portion 64 of wingassembly 26 may include skive portions 70 to assist in the folding ofwings 66 and 68 from the laterally extending position to the dorsalposition.

Referring to FIG. 1, shieldable needle device 12 includes tip guardassembly 24. Tip guard assembly 24 extends co-axially about needlecannula 20 and is axially movable along needle cannula 20 between aproximal position (FIGS. 2-5) adjacent hub 22 and a distal position(FIGS. 6-8) adjacent puncture tip 38 of needle cannula 20, as will bedescribed in more detail later. With tip guard assembly 24 in the distalposition, tip guard 24 protectively surrounds distal end 34 of needlecannula 20.

Tip guard assembly 24 includes a tip guard housing 72 and a protectiveclip 74. Housing 72 is a unitary structure, desirably molded from athermoplastic material, including a proximal end 76, a distal end 78, arecessed slot area 80 located at proximal end 76, and an internalchamber 82 (FIGS. 5 and 8) extending between the ends. A portion ofinternal chamber 82 adjacent distal end 78 defines an enlarged clipcavity 84, as shown in FIGS. 5 and 8. Additionally, tip guard assembly24 includes structure for mating with first drive member 28 and seconddrive member 30. For example, a first side surface 92 of distal end 78of tip guard housing 72 may include a connection element 86 forconnection with first drive member 28. An opposing second side surface94 of distal end 78 of tip guard housing 72 may also include aconnection element 86 for connection with second drive member 30. In oneembodiment, a first connection element 86 on first side surface 92 and asecond connection element 86 on second side surface 94 may each includea button element 88 for connection with first drive member 28 and seconddrive member 30, respectively. In other embodiments, tip guard housing72 may include different types of structures for mating with first drivemember 28 and second drive member 30 as will be described in more detailbelow and with reference to FIGS. 9A-11. Tip guard housing 72 alsoincludes a clip mounting post 90 (FIGS. 5 and 8) that extends downwardlyfrom tip guard housing 72 at a location near proximal end 76 of tipguard housing 72.

Protective clip 74 is unitarily stamped and formed from a resilientlydeflectable metallic material. Clip 74 includes a planar spring leg 96with a proximal end 98 and an opposed distal end 100. A mountingaperture 102 extends through spring leg 96 at a location adjacentproximal end 98. Mounting aperture 102 has a diameter approximatelyequal to or slightly less than the diameter of clip mounting post 90 oftip guard housing 72. In this manner, clip mounting post 90 can beforced through mounting aperture 102 when the axis of clip mounting post90 and the axis of mounting aperture 102 are substantially collinear.Clip 74 also includes a lock out leg 104 that extends from distal end100 of spring leg 96. The extending lock out leg 104 enables secureprotective engagement with puncture tip 38 of needle cannula 20 with tipguard assembly 24 in the distal position (FIGS. 6-8). The extending lockout leg 104 further enables smooth axial sliding movement of tip guardassembly 24 along needle cannula 20, as will be explained further below.

Hub 22 and tip guard assembly 24 are interconnected through first drivemember 28 and second drive member 30. First drive member 28 and seconddrive member 30 provide for axial movement of tip guard assembly 24along needle cannula 20 from a proximal position (FIGS. 2-5) adjacenthub 22 to a distal position (FIGS. 6-8) adjacent puncture tip 38 ofneedle cannula 20, as will be described in more detail later.

Referring to FIG. 1, shieldable needle device 12 includes first drivemember 28 and second drive member 30. As discussed above, first drivemember 28 is separate and distinct from second drive member 30. Firstdrive member 28 includes a body 110 having a proximal end 112 and anopposing distal end 114. Similarly, second drive member 30 includes abody 130 having a proximal end 132 and an opposing distal end 134.Bodies 110 and 130 are desirably formed of a resilient flexible materialcapable of bending and/or extending without an application of force,such as silicone. For example, prior to use, the drive members 28 and 30are in a folded biased position (FIGS. 2-5), and upon release of thewings 66 and 68, as will be described below, the drive members 28 and 30extend forward to an extended position (FIGS. 6-8). In this manner,first drive member 28 and second drive member 30 move tip guard assembly24 from the proximal position (FIGS. 2-5) to the distal position (FIGS.6-8).

Proximal end 112 of body 110 of first drive member 28 includes structurefor mating with hub 22. For example, in one embodiment, proximal end 112may include two proximal openings 116 for receiving the connectionelements 48 and 50 on first side surface 58 of distal end 42 of hub 22,thereby securing the proximal end 112 of first drive member 28 to thedistal end 42 of hub 22. Distal end 114 of body 110 of first drivemember 28 includes structure for mating with tip guard housing 72. Forexample, in one embodiment, distal end 114 of body 110 of first drivemember 28 may include a distal opening 118 to mate with first connectionelement 86 on first side surface 92 of tip guard assembly 24.

Similarly, proximal end 132 of body 130 of second drive member 30includes structure for mating with hub 22. For example, in oneembodiment, proximal end 132 may include two proximal openings 136 forreceiving the connection elements 48 and 50 on second side surface 60 ofdistal end 42 of hub 22, thereby securing the proximal end 132 of seconddrive member 30 to the distal end 42 of hub 22. Distal end 134 of body130 of second drive member 30 includes structure for mating with tipguard housing 72. For example, in one embodiment, distal end 134 of body130 of second drive member 30 may include a distal opening 138 to matewith second connection element 86 on second side surface 94 of tip guardassembly 24.

Alternatively or in addition to the mechanical mating structuredescribed above for the connection of drive members 28 and 30 to hub 22and tip guard assembly 24, respectively, the drive members 28 and 30 maybe connected to hub 22 and tip guard assembly 24 through the use of anadhesive or similar connection mechanism.

Since drive members 28 and 30 are connected to hub 22, and since thewings 66 and 68 extend laterally from hub 22, movement of the wings 66and 68 results in the corresponding movement of drive members 28 and 30.For example, with the wings 66 and 68 in the dorsal position (FIGS.2-5), the wings 66 and 68 retain the first drive member 28 and thesecond drive member 30 in the folded biased position thereby maintainingtip guard assembly 24 in the proximal position. Additionally, with thewings 66 and 68 in the dorsal position, a gap 150 (FIG. 4) is formedbetween hub 22 and the wings 66 and 68 thereby retaining a portion ofthe first drive member 28 and a portion of the second drive member 30internally within gap 150. In this manner, tip guard assembly 24 ismaintained in a proximal position adjacent hub 22. Upon release of wings66 and 68, wings 66 and 68 are free to move automatically from thedorsal position (FIGS. 2-5), in which the wings 66 and 68 are benttogether to form a unitary dorsal structure, to the relaxed, laterallyextending position (FIGS. 6-8). In this manner, first drive member 28and second drive member 30 are no longer retained by wings 66 and 68within gap 150, and first drive member 28 and second drive member 30 areable to unfold to the extended position (FIGS. 6-8) to move tip guardassembly 24 from the proximal position to the distal position. In otherwords, since first drive member 28 and second drive member 30 arefixedly attached to tip guard assembly 24, and since tip guard assembly24 is axially movable along needle cannula 20, the release of wings 66and 68 causes first drive member 28 and second drive member 30 to unfoldand axially move tip guard assembly 24 in a direction generally alongarrow B (FIG. 6) away from hub 22 and toward distal end 32 of needlecannula 20, where tip guard assembly 24 can effectively shield andprotectively surround puncture tip 38 of needle cannula 20.

Body 110 of first drive member 28 and body 130 of second drive member 30are formed of flexible materials that are biased toward the extendedposition, and therefore act as a means for storing energy to extendfirst drive member 28 and second drive member 30 toward distal end 34 ofneedle cannula 20 upon corresponding movement between wings 66 and 68 asdescribed above, thereby propelling tip guard assembly 24 from theproximal position (FIGS. 2-5) to the distal position (FIGS. 6-8).

As discussed above, different types of structures can be used to connectfirst drive member 28 or second drive member 30 to hub 22 or tip guardassembly 24. FIGS. 9A-11 illustrate exemplary embodiments of differenttypes of connection structures.

Referring to FIGS. 9A and 9B, a connection structure 200 includes adrive member receiving portion 202 and a locking portion 204 hingedlyconnected via a hinge 206. Drive member receiving portion 202 includes areceiving surface 208 and a post 210 extending from receiving surface208. Locking portion 204 defines an aperture 216 and includes latchmembers 212 having locking ends 214.

Referring to FIGS. 9A and 9B, a drive member 28A includes a body 110Ahaving a proximal end 112A defining an opening 116A. To secure drivemember 28A to connection structure 200, opening 116A of body 110A isdisposed over post 210 of drive member receiving portion 202 as shown inFIG. 9A. In this position, locking portion 204 can be pivoted in adirection generally along arrow C (FIG. 9A) about hinge 206 to thelocking position shown in FIG. 9B. In this locking position, post 210 ofdrive member receiving portion 202 is received within aperture 216 oflocking portion 204 and locking ends 214 of latch members 212 arelockingly engaged with drive member receiving portion 202 to provide asecure connection between drive member 28A and connection structure 200.Connection structure 200 can be used with hub 22 or tip guard assembly24 to securely connect first drive member 28 or second drive member 30to hub 22 or tip guard assembly 24.

Referring to FIG. 10, a connection structure 300 includes a drive memberreceiving portion 302 having a locking wall 304 at a distal end 308 anddefining a receiving channel 306 at a proximal end 312. Drive memberreceiving portion 302 also defines a drive member receiving slot 314 atdistal end 308. Referring to FIG. 10, a drive member 28B includes body a110B having a proximal end 112B and a protruding portion 120B locatedadjacent proximal end 112B. Protruding portion 120B may be formed of adeformable resilient material.

To secure drive member 28B to connection structure 300, protrudingportion 120B of body 110B of drive member 28B is inserted into receivingslot 314 of connection structure 300 so that protruding portion 120B canslide through and past locking wall 304. Because protruding portion 120Bis formed of a deformable resilient material, locking wall 304 candeform protruding portion 120B as protruding portion 120B slides throughreceiving slot 314. Once protruding portion 120B extends beyond lockingwall 304, protruding portion 120B is able to return back to its originalform as shown in FIG. 10. Once protruding portion 120B is in the lockedposition of FIG. 10, locking wall 304 forms a physical barrier thatlocks protruding portion 120B within slot 314 so that drive member 28Bcan not be pulled out of connection structure 300. Connection structure300 can be used with hub 22 or tip guard assembly 24 to securely connectfirst drive member 28 or second drive member 30 to hub 22 or tip guardassembly 24. For example, referring to FIG. 10, receiving channel 306 ofconnection structure 300 is capable of securely receiving a hub or a tipguard assembly 310.

Referring to FIG. 11, a connection structure 400 includes a drive memberreceiving portion 402 and a locking portion 404 hingedly connected via ahinge 406. Drive member receiving portion 402 includes a receivingsurface 408 and a post 410 extending from receiving surface 408. Lockingportion 404 defines an aperture 416 and includes a latch member 412having a locking end 414.

Referring to FIG. 11, a drive member 28C includes a body 110C having aproximal end 112C defining an opening 116C. To secure drive member 28Cto connection structure 400, opening 116C of body 110C is disposed overpost 410 of drive member receiving portion 402 as shown in FIG. 11. Inthis position, locking portion 404 can be pivoted in a directiongenerally along arrow D (FIG. 11) about hinge 406 to a locking position.In the locking position, post 410 of drive member receiving portion 402is received within aperture 416 of locking portion 404 and locking end414 of latch member 412 is lockingly engaged with drive member receivingportion 402 to provide a secure connection between drive member 28C andconnection structure 400. Connection structure 400 functions similarlyto connection structure 200 described above. Connection structure 400can be used with hub 22 or tip guard assembly 24 to securely connectfirst drive member 28 or second drive member 30 to hub 22 or tip guardassembly 24.

Assembly of shieldable needle device 12 may be accomplished as follows.Tip guard assembly 24 is assembled by forcing clip mounting post 90 oftip guard housing 72 through mounting aperture 102 of protective clip74. Spring leg 96 of clip 74 is then urged downwardly or away frominternal chamber 82 through tip guard housing 72. First drive member 28and second drive member 30 are then interconnected between tip guardassembly 24 and hub 22 by depressing proximal openings 116 and 136 overconnection elements 48 and 50 on respective side surfaces 58 and 60 ofhub 22 and depressing distal openings 118 and 138 over connectionelement 86 on respective side surfaces 92 and 94 of tip guard assembly,respectively, as described above. Distal end 34 of needle cannula 20 isthen passed through central passage 44 of hub 22, and urged intointernal chamber 82 at proximal end 76 of tip guard housing 72. Thedownward deflection of spring leg 96 enables distal end 34 of needlecannula 20 to be passed entirely through tip guard housing 72 as shownin FIG. 5. Spring leg 96 can be released after puncture tip 38 of needlecannula 20 passes entirely through tip guard housing 72. In this manner,the end of lock out leg 104 will be biased against and slide alongneedle cannula 20. Tip guard assembly 24 is then slid proximally alongneedle cannula 20 into a position adjacent hub 22, with first drivemember 28 and second drive member 30 each folded over itself into abent, biased position, primed for use, as shown in FIGS. 2-5. Wings 66and 68 are then bent toward each other in the dorsal position to form adorsally mating structure as shown in FIGS. 2-5. Packaging cover 18 isthen urged over puncture tip 38 and urged proximally over needle cannula20, with puncture tip 38 safely maintained and disposed within packagingcover 18, and with a lateral wall 17 and a slot 19 of packaging cover 18maintaining wings 66 and 68 in the bent dorsal position as shown inFIGS. 2 and 3. Packaging cover 18 is desirably constructed of a rigidmaterial which is capable of maintaining wings 66 and 68 in the dorsalposition.

As discussed above, blood collection assembly 10 can be packagedsubstantially in the condition shown in FIG. 2 in protective packaging,such as in a blister package. Prior to use, blood collection assembly 10is removed from any protective package, and fixture 16 may be connectedto an appropriate receptacle for providing fluid communication withlumen 36 extending through needle cannula 20.

In use, blood collection assembly 10 is provided with shieldable needledevice 12 assembled and including flexible tube 14 extending fromshieldable needle device 12 and connected to fixture 16. After removingblood collection assembly 10 from its protective packaging, it can beassembled with other appropriate medical equipment for use. For example,a non-patient needle assembly and a needle holder may be connected toblood collection assembly 10 through fixture 16.

To prepare for use of blood collection assembly 10, the user graspsblood collection assembly 10 at shieldable needle device 12, placing athumb and forefinger on wings 66 and 68, with wings 66 and 68 maintainedin a dorsal position between the user's fingers, as shown in FIG. 3.Both wings 66 and 68 are preferably flexed or bent toward each otherbetween a user's thumb and forefinger with bodies 110 and 130 of firstand second drive members 28 and 30 trapped therebetween. Packaging cover18 is then grasped and urged distally in a direction generally alongarrow A (FIG. 3) to disengage cover 18 from needle cannula 20, therebyexposing puncture tip 38 of needle cannula 20.

The medical practitioner can then urge puncture tip 38 at distal end 34of needle cannula 20 into a targeted blood vessel of a patient, whilewings 66 and 68 are maintained between thumb and forefinger to assist ina controlled entry by the medical practitioner. Tip guard assembly 24 ismaintained in the proximal position (FIGS. 3-5) due to the grip by theuser's fingers between wings 66 and 68, which maintains first drivemember 28 and second drive member 30 in the folded, biased position.

After the targeted blood vessel has been accessed, the medicalpractitioner can release wings 66 and 68. Once the user releases thedevice, first drive member 28 and second drive member 30 are free tomove from the folded biased position to the extended unfolded position,due to the bias exerted by bodies 110 and 130 of first drive member 28and second drive member 30 through release of wings 66 and 68. Suchmovement causes bodies 110 and 130 of first drive member 28 and seconddrive member 30 to extend, thereby propelling tip guard assembly 24distally along needle cannula 20 in an axial direction generally alongarrow B (FIG. 6), with tip guard assembly 24 sliding or gliding alongneedle cannula 20 toward distal end 34. Distal movement of tip guardassembly 24 will terminate when distal end 78 of tip guard housing 72contacts the skin of the patient near the puncture site.

Upon completion of the procedure, such as when all desired samples havebeen drawn, needle cannula 20 is withdrawn from the patient. Thisremoval of needle cannula 20 from the patient will permit furtherextension of bodies 110 and 130 of first drive member 28 and seconddrive member 30 and a corresponding distal movement of tip guardassembly 24 in an axial direction generally along arrow B (FIG. 6).After tip guard assembly 24 is moved along needle cannula 20 to thedistal end 34, lock out leg 104 of clip 74 will pass distally beyondpuncture tip 38 of needle cannula 20. The inherent resiliency of springleg 96 of clip 74 will urge lock out leg 104 over puncture tip 38 ofneedle cannula 20 as shown in FIG. 8. In this manner, a return movementof tip guard assembly 24 to the proximal position is prevented.Furthermore, first drive member 28 and second drive member 30 haveoverall dimensions that will prevent movement of tip guard assembly 24distally beyond needle cannula 20. In this manner, puncture tip 38 ofneedle cannula 20 is safely shielded. Blood collection assembly 10 maythen be appropriately and safely discarded.

Since wings 66 and 68 are initially bent in a dorsal position, wings 66and 68 can act as a handle portion during insertion, withdrawal, anddisposal of shieldable needle device 12. In particular, after release ofwings 66 and 68 to propel tip guard assembly 24 to the distal position,the needle cannula 20 is shielded and wings 66 and 68 extend laterallyfrom hub 22. Since wings 66 and 68 include at least some flexibleportion, wings 66 and 68 can be bent to a dorsal position, as shown inFIG. 4, to allow a user to grip the shieldable needle device 12 forremoval from the patient. The wings 66 and 68 can also act as a handleportion for carrying blood collection assembly 10 at a position remotefrom the used needle tip of cannula 20. Additionally, first drive member28 and second drive member 30 can be actuated while puncture tip 38 iswithin the patient's blood vessel, thereby beginning axial movement oftip guard assembly 24 along needle cannula 20. In other embodiments,first drive member 28 and second drive member 30 can be actuated afterpuncture tip 38 is removed from the patient's blood vessel.

The shielding feature of the present invention is passively activatedupon normal usage of the device. In particular, upon removal of thepackaging cover prior to insertion, the safety feature is primed andcharged, ready for shielding the needle once the user releases the wingstructure after insertion into a patient. Moreover, as described above,passive shielding of the needle cannula is automatically achieved merelyby removing the needle cannula from the patient.

In some instances, the needle device may be dropped or knocked from thehand of the medical practitioner either before venipuncture or during amedical procedure. The passive shielding described above will commenceautomatically when the needle device is dropped or knocked from themedical practitioner's hand. Thus, the automatic shielding may betriggered by the intentional or unintentional release of the wings bythe medical practitioner.

Moreover, a medical practitioner does not always enter the targetedblood vessel during the first venipuncture attempt. However, a medicalpractitioner typically retains a close grip on the needle device untilthe targeted blood vessel has been entered. In this manner, thecontinued gripping of the wings will prevent the needle from shieldinguntil the targeted blood vessel has been punctured. The second attemptat accessing a targeted blood vessel generally is a very low riskprocedure in which the practitioner's hand is spaced considerably fromthe puncture tip of the needle cannula. Thus, the blood collection setaccording to the present invention does not involve the inconvenience ofhaving to use a new blood collection set following each unsuccessfulvenipuncture attempt.

While the needle assembly of the present invention has been described interms of one embodiment for use in connection with a blood collectionsystem, it is further contemplated that the needle assembly could beused with other medical procedures, such as in conjunction with aconventional intravenous infusion set, which are well known in the artfor use with needle assemblies.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A shieldable needle device comprising: a needlecannula having a proximal end and a distal end; a hub supporting atleast a portion of the needle cannula; a wing assembly having at least apair of wings extending from opposing sides of the hub, the pair ofwings movable between a laterally extending position and a dorsalposition; a tip guard axially movable with respect to the needle cannulafrom a first position adjacent the hub to a second position in which thetip guard shields the distal end of the needle cannula; and a drivemember extendable between a biased position and an extended position formoving the tip guard from the first position to the second position, thedrive member having a proximal end engaged with the hub and a distal endengaged with the tip guard, wherein, with the pair of wings in thedorsal position, the pair of wings retain the drive member in the biasedposition thereby maintaining the tip guard in the first position, andmovement of the pair of wings from the dorsal position to the laterallyextending position releases the drive member thereby allowing the drivemember to transition to the extended position and advance the tip guardfrom the first position to the second position.
 2. The shieldable needledevice of claim 1, further comprising a second drive member extendablebetween a biased position and an extended position for moving the tipguard from the first position to the second position, the second drivemember having a proximal end engaged with the hub and a distal endengaged with the tip guard.
 3. The shieldable needle device of claim 2,wherein, with the pair of wings in the dorsal position, the pair ofwings retain the drive member and the second drive member in the biasedposition thereby maintaining the tip guard in the first position.
 4. Theshieldable needle device of claim 3, wherein movement of the pair ofwings from the dorsal position to the laterally extending positionreleases the drive member and the second drive member, thereby allowingthe drive member and the second drive member to transition to theextended position and advance the tip guard from the first position tothe second position.
 5. The shieldable needle device of claim 2, whereinthe proximal end of the drive member is connected to an opposite side ofthe hub from the proximal end of the second drive member.
 6. Theshieldable needle device of claim 2, wherein the distal end of the drivemember is connected to an opposite side of the tip guard from the distalend of the second drive member.
 7. The shieldable needle device of claim1, further comprising a cover protectively surrounding the needlecannula and maintaining the pair of wings in the dorsal position.
 8. Theshieldable needle device of claim 7, wherein the cover defines a slotarea for receiving and maintaining the pair of wings in the dorsalposition.
 9. The shieldable needle device of claim 1, wherein the pairof wings are formed with the hub.
 10. The shieldable needle device ofclaim 1, wherein the pair of wings are formed of a resilient flexiblematerial.
 11. The shieldable needle device of claim 1, wherein the drivemember is formed of a resilient flexible material.
 12. The shieldableneedle device of claim 1, wherein the tip guard comprises a tip guardhousing formed from a plastic material and a metallic spring clipmounted to the tip guard housing, the spring clip biased against theneedle cannula with the tip guard in the first position and the springclip disposed over the distal end of the needle cannula with the tipguard in the second position.
 13. The shieldable needle device of claim1, wherein the drive member is at least partially folded in the biasedposition.
 14. The shieldable needle device of claim 2, wherein both thedrive member and the second drive member are at least partially foldedin the biased position.
 15. A shieldable needle device comprising: aneedle cannula having a proximal end and a distal end; a hub supportingat least a portion of the needle cannula; a wing assembly having atleast a pair of wings extending from opposing sides of the hub, the pairof wings movable between a laterally extending position and a dorsalposition, and with the pair of wings in the dorsal position a gap isformed between the hub and the pair of wings; a tip guard axiallymovable with respect to the needle cannula from a first positionadjacent the hub to a second position in which the tip guard shields thedistal end of the needle cannula; and a drive member extendable betweena biased position and an extended position for moving the tip guard fromthe first position to the second position, the drive member having aproximal end engaged with the hub and a distal end engaged with the tipguard, wherein, with the pair of wings in the dorsal position and thedrive member in the biased position, a portion of the drive member isretained within the gap between the hub and the pair of wings.
 16. Theshieldable needle device of claim 15, further comprising a second drivemember extendable between a biased position and an extended position formoving the tip guard from the first position to the second position, thesecond drive member having a proximal end engaged with the hub and adistal end engaged with the tip guard.
 17. The shieldable needle deviceof claim 16, wherein with the pair of wings in the dorsal position andthe drive member and the second drive member in the biased position, aportion of at least one of the drive member and the second drive memberis retained within the gap between the hub and the pair of wings. 18.The shieldable needle device of claim 16, wherein with the pair of wingsin the dorsal position and the drive member and the second drive memberin the biased position, a portion of both the drive member and thesecond drive member is retained within the gap between the hub and thepair of wings.
 19. The shieldable needle device of claim 18, wherein thepair of wings retains the drive member and the second drive member in afolded position thereby maintaining the tip guard in the first position,and movement of the pair of wings from the dorsal position to thelaterally extending position releases retainment of the drive member andthe second drive member thereby allowing the drive member and the seconddrive member to unfold to the extended position and move the tip guardfrom the first position to the second position.
 20. The shieldableneedle device of claim 16, wherein the drive member is separate from thesecond drive member.
 21. The shieldable needle device of claim 16,wherein the proximal end of the drive member is connected to an oppositeside of the hub from the proximal end of the second drive member. 22.The shieldable needle device of claim 16, wherein the distal end of thedrive member is connected to an opposite side of the tip guard from thedistal end of the second drive member.
 23. The shieldable needle deviceof claim 15, wherein the drive member is formed of a resilient flexiblematerial.
 24. The shieldable needle device of claim 15, wherein the tipguard comprises a tip guard housing formed from a plastic material and ametallic spring clip mounted to the tip guard housing, the spring clipbiased against the needle cannula with the tip guard in the firstposition and the spring clip disposed over the distal end of the needlecannula with the tip guard in the second position.
 25. A shieldableneedle device comprising: a needle cannula having a proximal end and adistal end; a retainer member supporting the proximal end of the needlecannula, the retainer member movable between an open position and aretaining position; a tip guard axially movable with respect to theneedle cannula from a first position adjacent the retainer member to asecond position in which the tip guard shields the distal end of theneedle cannula; a first drive member extendable between a biasedposition and an extended position for moving the tip guard from thefirst position to the second position, the first drive member having aproximal end connected to the retainer member and a distal end connectedto the tip guard; and a second drive member extendable between a biasedposition and an extended position for moving the tip guard from thefirst position to the second position, the second drive member having aproximal end connected to the retainer member and a distal end connectedto the tip guard, wherein, with the retainer member in the retainingposition, the retainer member retains the first drive member and thesecond drive member in the biased position thereby maintaining the tipguard in the first position, and movement of the retainer member fromthe retaining position to the open position releases retainment of thefirst drive member and the second drive member thereby allowing thefirst drive member and the second drive member to transition to theextended position and move the tip guard from the first position to thesecond position.
 26. The shieldable needle device of claim 25, whereinthe first drive member and the second drive member are at leastpartially folded in the biased position.
 27. The shieldable needledevice of claim 26, wherein movement of the retainer member from theretaining position to the open position releases retainment of the firstdrive member and the second drive member thereby allowing the firstdrive member and the second drive member to unfold to the extendedposition and move the tip guard from the first position to the secondposition.